Botswana Diarrheal Diseases Study

HIV Infections Clinical Trial

Official title:

Botswana Diarrheal Diseases Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197652
• Other study ID #: K23HD001330-05
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 6, 2011
• Start date: March 2001
• Est. completion date: March 2008

Study information

• Verified date: October 2011
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goals of this study are to:

1. determine the diarrheal rates, morbidity, mortality, and pathogens present among breast-fed infants born to HIV-infected mothers.

• analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts of infected mothers.

• comparison to rates among infants born to HIV uninfected mothers.

2. link analysis of the functional quality of immunoglobulins in the breast milk of HIV-infected and uninfected mothers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1350
• Est. completion date: March 2008
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject is able to provide independent informed consent.

• Subject is able to complete a questionnaire as part of her enrollment visit and agrees to complete follow-up questionnaires monthly.

• Subject presents symptoms of acute diarrhea: at least 3 loose stools during 24 hours as reported by mother; persistent diarrhea: an episode of diarrhea lasting 14 days; recurrent diarrhea: a new episode of diarrhea after an interval of at least two diarrhea-free days.

For HIV-infected subjects:

• Mother: HIV antibody is detected by dual HIV-1 ELISA and confirmed by western blot. Infant: HIV antigen is detected by PCR on 2 samples during the follow-up period, or on 1 sample followed by the death of the infant.

Exclusion Criteria:

• Subject cannot provide legal independent informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Botswana	Princess Marina Hospital	Gaborone

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Botswana Ministry of Health

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCCURRENCE OF SUSPECTED PNEUMONIA OR BLOODSTREAM INFECTION OVER FIRST TWO YEARS OF LIFE		24 months	No